Tag: Anti-Kickback Statute

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Telehealth’s Weight-Loss Boom and the Corporate Practice of Medicine

Telehealth weight-loss platforms offering rapid GLP-1 prescriptions have become one of the fastest-growing segments in healthcare. These platforms connect consumers with clinicians via virtual consultations to assess eligibility for drugs like semaglutide or tirzepatide. This model has attracted significant venture capital as demand surges. Yet, behind the glossy marketing and rapid expansion lies a longstanding …

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The 9th Circuit’s EKRA Ruling: Implications For Behavioral Health and Clinical Labs

Previously published in Healthcare News and Healthcare Michigan Recently, the Ninth Circuit Court of Appeals affirmed a conviction of a lab operator for violations of the Eliminating Kickbacks in Recovery Act (“EKRA”) in United States v. Schena. This ruling, the first ever appellate interpretation of EKRA, has notable implications for both the laboratory industry and the greater healthcare industry. …

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Practice Buy-Sell Agreements: Drafters Beware

Originally published in Healthcare Michigan, Volume 41,  No. 5 My prior article addressed tax issues in repurchasing equity in physicians and other practice groups. This article provides information about drafting buy-sell agreements for practice entities that include provisions for repurchasing equity from owners. These agreements limit an owner’s ability to transfer equity and require its sale …

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Sixth Circuit Defines False Claims Standards

The Federal False Claims Act (“FCA”) imposes civil liability for presenting a false claim to the government for payment. The Federal Anti-Kickback Statue (“AKS”) prohibits medical providers from making referrals in return for “remuneration.”  In a recent decision by the Sixth Court of Appeals, the Court found that a hospital’s decision not to hire an …

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Anti-Kickback Statute and Stark Law Recent Updates

Those serving in the health care industry are all too familiar with the Anti-Kickback Statute and the Stark Law – physician self-referral and fraud and abuse laws that prohibit financial payments or incentives for referring patients, specifically a Medicare or Medicaid patient. In December 2020, The Officer of Inspector General (OIG) Final Rule and the …

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The Regulatory Sprint to Value-Based Care

On December 2, 2020, the CMS and the OIG published the rules modifying the safe harbors under the Anti-Kickback Statute[1] and exceptions under the Stark Law[2]. This article presents an overview of the value-based rules, which became effective on January 19, 2021. CMS and OIG coordinated many aspects of the value-based rules, and this section …

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New Safe Harbors for Telehealth

New and modified safe harbors to the Stark Law and Anti-Kickback statue allow healthcare providers and entities more flexibility to create and expand telehealth platforms in compliant fashion. On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) finalized the rules modifying the safe harbors …

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The OIG’s FAQs Related to COVID-19

The  Office of the Inspector General (“OIG”) for the Department of Health and Human Services (“HHS”) has developed a process for interested parties to obtain regulatory compliance guidance from the OIG prior to pursuing  arrangements related to COVID-19. The OIG has dubbed this process FAQs–Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the Coronavirus Disease …

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Compliance Outside of Health Care

Many providers are familiar with compliance in a health care context. They know to make agreements compliant with the Stark Law and the Anti-Kickback Statute, for instance. But the keys to a good compliance system (policies and procedures, designation of a compliance officer/committee, training and education, communication, ethics and culture, top-down compliance, enforcement, auditing and …

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Kicking Off 2020 with Anti-Kickback Statute and Stark Law Reforms: What You Need to Know

You’ve probably heard that every provider’s favorite laws, the Anti-Kickback Statute and its related, strict liability counterpart, the Stark Law (formally known as the Physician Self-Referral Law), are getting a makeover from the Department of Health and Human Services (HHS). Here’s what you need to know. Quick Legal Refresher: (A) What is the Anti-Kickback Statute? …

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